Trial document




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  DRKS00017078

Trial Description

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Title

Implementation of internet- and tele-based prevention programs to improve mental health and to prevent the onset of mental disorders in agriculturists: Implementation study to evaluate a national prevention program

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Trial Acronym

ImpleMentIT (Implementation of internet- and tele-based prevention programs)

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URL of the Trial

http://www.psych1.phil.uni-erlangen.de/forschung/internetbasierte-therapie/mit-uns-im-gleichgewicht.shtml

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Brief Summary in Lay Language

The study is integrated in a project financed by a social insurance company (SVLFG), which aims to promote mental wellbeing among agriculturists, gardeners, and foresters.
The project is scientifically evaluated by the Friedrich-Alexander-University Erlangen-Nürnberg and the University Ulm.
Preventive services for the reduction of mental stress is particularly important for so called green professions (e.g. foresters, gardeners, farmers), because this group shows a higher risk for developing a depressive disorder due to demanding working conditions (e.g. high workload, family conflicts, seasonal work). The primary objective of the research project is to measure and evaluate the implementation success of internet- and tele-based prevention services in standard care. In addition, different rollout-regions and services will be compared.
Part of the study are surveys with policyholders of the SVLFG as well as with staff members of involved organizations (SVLFG, Get.ON and IVP). Evidence about effectiveness, acceptance, satisfaction and sustainability of the prevention services will be gathered. Additionally, interviews with participants will be carried out to get insights into the experiences with the interventions. Furthermore, the efficiency of the entire implementation will be evaluated. If the implementation of the prevention services is successful, the long-term sustainability is aim of this project.

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Brief Summary in Scientific Language

The implementation of internet- and tele-based prevention services occurs step-by-step based on a rollout-plan following a pilot implementation phase in Bavaria and Schleswig-Holstein. Objective of the implementation study is the evaluation of implementation outcomes and processes and differences between the preventive services (Get.ON, IVP) and the rollout-regions. The success of the implementation is regarded as a multidimensional construct and evaluated on the basis of the dimensions of „RE-AIM“-framework (Reach, effectiveness, adoption, implementation and maintenance) as well as „Consolidated Framework for Implementation Research“ (CFIR) in the context of a mixed-methods-design, which consists of qualitative interviews, focus groups, quantitative data and reporting-data. The target group are the policyholders of the SVLFG, the staff and service providers of involved organizations (SVLFG, Get.On and IVP) and the campaign team.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Anonymous data can be used for research purposes within the EU.

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Organizational Data

  •   DRKS00017078
  •   2019/04/18
  •   [---]*
  •   yes
  •   Approved
  •   485_18B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   prevention of mental disorder and improvement of mental health
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Interventions/Observational Groups

  •   The interventions are introduced step-by-step in three rollout-regions following a pilot implementation phase in a pilot region. But the interventions are not randomized and controlled, but implemented in the standard care.
    One intervention includes Get.ON online health trainings (self-help tool), these are seven separate trainings: Get.On trainings for mood, stress, regeneration, diabetes and depression, panic, chronical pain and drinking problems.
  •   Another intervention, the IVP services, include an individual telephone-coaching, in which the participants talk to specifically trained psychologists by telephone for 3-6 months.
    In addition, the service contains a crisis hotline, if necessary a need analysis and finding a therapist or external consulting centers.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary objective of the research project is the measurement, evaluation and comparison of the implementation success of internet- and tele-based prevention offers in standard care. The intervention services (Get.On trainings, IVP services) will be evaluated with the dimensions of the „RE-AIM“-framework: reach, effectiveness, adoption, implementation and maintenance. The data of the participants (T) and staff members (M) will be collected on T0/M0, T1 (Get.On trainings after 3 months, IVP telephone coaching after 6 months), M1 (after 6 months) T2/M2 (after 12 months) and M3 (after 18 months).

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Secondary Outcome

Qualitative interviews (participants) and results of focus groups (staff members) will be analyzed, beginning in Summer 2019. In addition, negative effects, barriers and beneficial factors as well as uptake-criteria (e.g. consulting on services, start of intervention, complete participation at intervention, drop-outs…) will be examined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/05/06
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Persons involved in the process: Involved in consultation (SVLFG and other organizations) or provision of the health interventions (Get.On, IVP);
Implementation/administration team of the organization by providing the new prevention services;
Policyholders: Policyholders of the Landwirtschaftliche Krankenkasse (LKK) and Landwirtschaftliche Alterskasse (LAK), who have given their consent for the participation and have access to a telephone and computer/laptop.

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Exclusion Criteria

No informed consent;
Persons involved in the process: Staff members of the SVLFG, who have already participated in the pilot implementation or participate in other studies;
Policyholders: Persons, who suffer from a disorder and a treatment is indicated.
The tele centrum and the service providing organizations (IVP, GET.ON) will check, whether the policyholder has sufficient verbal, intellectual and motivational skills for participating in the intervention. Otherwise other measures will be examined and the participant will be excluded.
Visual impairment excludes online interventions and impaired hearing excludes tele-based interventions.

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Addresses

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    • Lehrstuhl für Klinische Psychologie und PsychotherapieFriedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Matthias Berking 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie der FAU
    • Ms.  M.Sc.  Ingrid  Titzler 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie der FAU
    • Ms.  M.Sc.  Johanna  Freund 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Sozialversicherung für Landwirtschaft, Forsten und Gartenbau
    • Weißensteinstraße 70 - 72
    • 34131  Kassel
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.